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Today’s guest post is from Nick Dellefave, an up and coming Holland & Knight litigator.  The Blog has rolled out a few posts on the latest edition of the Reference Manual on Scientific Evidence.  Nick adds to this opus with a dive into the intersection between scientific evidence, the role of trial judges, and this thing called “artificial intelligence,” which the Blog has also touched on from time to time.  As always, the guest poster deserves all of the credit and/or blame for the post.  (At a minimum, Nick gets some credit for allowing us to not have to write a post while on vacation.)

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As we covered last month, the new Reference Manual on Scientific Evidence is here, complete with a new chapter on Artificial Intelligence.  While the entire chapter should be required reading for litigators practicing in 2026, today we are focusing on one key subsection, titled “Judges as AI Gatekeepers.”  It offers a window into how courts will evaluate AI-generated evidence, and more importantly, where the pressure points are for both sides.  We thought it would be useful to pull out the key takeaways for practitioners who may be dealing with AI evidence sooner than they think.  This subsection has not drawn the attention of the climate science chapter, but it may end up being more impactful.

The Familiar Rules, Applied Unfamiliarly

Here is the good news: AI evidence will be evaluated under the evidentiary rules we all know and love.  The not-so-good news is that applying those rules to AI is anything but straightforward.  Under Federal Rule of Evidence 401, AI applications are essentially probability assessment tools, theoretically making them inherently relevant when offered to demonstrate whether something is “more or less probable.”  But Rule 403 gives courts plenty of room to exclude AI evidence when it risks unfair prejudice, confusion, or misleading the jury.  This is likely to be a prime battleground in determining the admissibility of AI evidence, as litigators and judges will rightfully ask whether the AI’s probative value is substantially outweighed by these dangers.

If you are challenging AI evidence, be ready to argue that certain outputs are too inaccurate or biased to be relevant, or that they are simply a poor fit for the purpose offered.  Courts may exclude AI evidence under Rule 403 precisely because juries tend to assume that if a computer said it, it must be true.  One need only look around at the epidemic of advertisers boasting “AI-powered” products to see this concept in action.  The imprimatur of “science” or “technology” can lend AI evidence a false authority it may not deserve.  Of course, with changes in jury attitudes about science and experts, it is hard to be sure how AI evidence will be received when its source is revealed.  If you are opposing AI evidence, hammer this point.  If you are the proponent, be prepared to show that the evidence is reliable and appropriately scoped for the purpose for which you are offering it.

Discovery Is Where the Action Is

The foundation for admissibility fights over AI evidence will be laid in discovery, which promises to generate its own fights.  Opponents seeking to challenge AI evidence will need access to the underlying algorithm, the training data, and knowledge of what is happening inside that machine-learning black box.  If you are challenging AI evidence, go after this information aggressively.  If you are the proponent, decide early on how you will address those requests, because rest assured, they are coming.  For more on this, see our recent discussion on Discovery of Artificial Intelligence Prompts. 

Of course, there is tension here with trade secret protection.  AI developers are not exactly eager to open up their proprietary algorithms for public inspection.  Courts have tools to navigate this: they can seal records, use protective orders, and exercise their general power to oversee how evidence comes in.  The Defend Trade Secrets Act (18 U.S.C. § 1835) also gives courts specific direction to protect trade secrets in relevant proceedings.  Attorneys should be prepared to negotiate protective orders and in camera review procedures.

Daubert, But Make It Complicated

Daubert as spelled out in the enhanced Rule 702 is, of course, the go-to framework for expert testimony, but applying its factors to AI is trickier than it sounds.  Every AI application is different: different algorithms, different machine learning methodologies, different training data.  This means AI issues are generally not going to be resolved the way DNA analysis was.  There will not be a single landmark case that settles the question of when AI evidence comes in.  Instead, expect adjudication for each application and each context.

The question of testability—the hallmark of Daubert/Rule 702 analysis—is complicated by the multiple inputs into an AI engine system.  The threshold question is: what exactly are we testing?  The sensors?  The algorithm?  The math?  The training data?  The system as a whole?  Similarly, credible peer review requires access to the underlying algorithm, parameter weights, and training data.  If the AI evidence being offered has not been meaningfully peer reviewed, and if that review did not include the underlying code and data, that is a vulnerability to exploit.

Error rates are another minefield.  Attorneys must ask whether error rates vary depending on whether the AI was tested using the relevant local population to which it will be applied, as opposed to a national population or idealized lab database.

Context and Bias: The Low Hanging Fruit

Attorneys should scrutinize whether the AI application is a good “fit” for the purpose for which it is proffered.  Is the AI application actually designed for the purpose it is being used for?  Some algorithms are built for one thing and then repurposed for another—with predictably dicey results.  The Manual’s authors cite the example of criminal risk assessment algorithms, which might be designed to determine who would benefit from alternatives to incarceration, but are probably inapt for use in sentencing determinations.  More applicable to readers of this blog, algorithms designed to model drug or device efficacy might be inapt for use in modeling the incidence of adverse effects.

Even when an algorithm is being used for its intended purpose, it may perform worse in certain contexts because of how it was trained.  An AI trained on one population may not achieve the same accuracy when applied to a different demographic.  If there is a mismatch between the training population and the population at issue in your case, that disparity is ripe for attack.

There is also the risk that neural networks rely on inapt factors—i.e., things they should not be considering—in making their predictions.  Judges are going to want to know whether inappropriate or unconstitutional factors were included, and whether any factors are working as proxies for suspect categories like race.  Demand disclosure of what factors are in the model and how they are weighted.  You may not get it easily, but in many cases, this is a fight worth having.

Deepfakes and the Importance of Witness Authentication

The Manual’s authors devote several pages to the problems posed by deepfakes.  Deepfake technology is only getting better, cheaper, and more accessible.  Practitioners should prepare for increased litigation over the authenticity of photos, videos, and audio recordings, as the mere availability of deepfake technology throws the authenticity of all types of evidence into doubt.

Under Rule 901, the proponent has to produce evidence sufficient to show the item is what it claims to be.  But here is the problem: your authenticating witness may not be able to tell whether the evidence is genuine or fake.  Deepfakes can shade human memory.  Archive systems can be hacked.  Digital forensic experts are going to be in high demand, and rightly so.

On the authentication front, there are some tools worth knowing about.  Federal Rules of Evidence 902(13) and 902(14), adopted back in 2017, provide for self-authentication of certified electronic records and certified data copied from electronic devices.  Items with cryptographic hashes may be authenticated under these rules, subject to the adverse party’s “fair opportunity to challenge.”  Although litigators may be accustomed to stipulating to the authenticity of electronic evidence, in this age of deepfakes, they should be increasingly wary of waiving these challenge opportunities without consulting a digital forensic expert.

So What Should You Actually Do?

If you are offering AI evidence, line up your expert testimony now.  As we have argued, admission of AI evidence likely requires the proponent to offer an expert who can speak credibly to the AI’s design, training, validation, and accuracy.  Your goal should be to simplify the foundational requirements and make the evidence as easy to admit as possible.  If you are opposing AI evidence, your job is the opposite: attack relevance and reliability, demand discovery of algorithms and training data, and prepare to cross-examine the software engineers who built the system.

We expect that AI evidence will continue to be an area where the rules are being written in real time.  Practitioners should understand that courts are going to face layered adjudicative challenges every time AI evidence comes up.  As the chapter’s authors put it, “the most important thing courts can do is ask careful and informed questions.”  That means the most important thing you can do as an advocate is be ready to answer them well.

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Who would’ve thought that Texas, of all states, would become a nannyocracy? The Lone Star State typically positions itself as the home of rough and ready folks who can take care of themselves.  Think Jim Bowie, Willie Nelson, or Bob Lilly, not Mr. Rogers, Mary Poppins, or Nanny McPhee. Texans don’t need the government telling them to steer clear of things that might pose risks.  Let California and Massachusetts hover over its meek, ready-to-be-victim citizens.  Texans are tough, and they’re fixing to get ready to clobber you if you lecture them on healthier lifestyles.  

So how to account for Section 9 of Texas Senate Bill 25, codified in Texas Health & Safety Code section 431.0815(a), which requires food and beverage companies to include conspicuous warnings on products that contain any of 44 listed ingredients (subject to some exceptions)?  As the folks on the excellent Commentary podcast would say, it gets even worse than that. Here is what the warning must say: “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.”  Since when do Texans care what effete, warm-beer drinking, Speedo-wearing, surrender-monkeys say about anything? [WARNING: We are joking.  We admire all those countries.  We like visiting them. If our nation was going to mimic another country’s health warnings, those places would probably be the best ones to mimic.  But (1) it should be the Food and Drug Administration (FDA), not various and sundry states or, worse, state juries, that should do the mimicking, and (2) it turns out that Texas is not even accurately mimicking those countries’ health determinations, which is another reason why the statute should be enjoined.]

Section 9 contains a federal preemption provision that calls off the warning requirement if the FDA or United States Department of Agriculture issue a law or regulation pertaining to one of the 44 listed ingredients prohibiting or conditioning use or determining it to be safe or imposing a particular labeling statement.  Section 9 was to take effect on January 1, 2027. 

In American Beverage Ass’n et al. v. Paxton, 2026 WL 395513 (W.D. Texas Feb. 11, 2026), a collection of nonprofit entities representing manufacturers and marketers of consumer packaged foods and beverages filed a lawsuit challenging the Texas law.  The defendant is the Attorney General of Texas.  He is running in the Republican primary against incumbent Senator Jon Cornyn.  Paxton aims to win by out MAGA-ing Cornyn.  MAGA now includes MAHA (Make America Healthy Again), and, somehow, right-wing politicians (who used to abhor anything smacking of “international law”) find themselves allied with a science-rejecting Health and Human Services Secretary who hates vaccines and seed oils, tinkers with bear corpses, and brags about how he sniffed cocaine off toilet seats.  As the Tommy Lee Jones character mutters near the end of No Country for Old Men (set in West Texas), “signs and wonders.”

Section 9 seems flat-out silly, but being silly is not ordinarily enough to strike down a law (though such silliness can be a factor in the court’s analysis).  The smart folks at the ABA (those are the liquor folks, not the lawyer folks) and other associations came up with a variety of legal arguments.  The one that persuaded the court to enjoin Texas’s ballyhooed attempt to impose its own ingredient labeling requirements (again, partly borrowed from NATO allies that our government keeps insulting and tariffing) was — tada! — free speech. The court reasoned that the plaintiffs would likely win on the argument that Section 9 is barred by the First Amendment.  That is an important result, because the First Amendment attack is often available when the government tries to force certain kinds of speech. Admittedly, when we frame a motion against such forced speech, the First Amendment argument usually does not come, er, first, because we expect to run into judicial skepticism.  Vagueness, over breadth, and preemption usually get higher billing. But maybe this recent case should prompt us to rethink that. 

The court held that the Texas non-FDA labeling requirements are a form of “compelled speech” over a subject matter that is anything but settled and non-controversial.   A lot of the arguments between the parties focused on whether the case involved a content regulation that called for strict scrutiny, or whether it was a commercial speech case that called for intermediate scrutiny. The implicit assumption was that strict scrutiny would mean that the statute was dead, while intermediate scrutiny would mean that the ABA’s lawsuit was dead.  (You’ve doubtless heard the rubric “strict in theory, fatal in reality.”) That dichotomy turned out not to be true here, and how the court got there was interesting. 

The court held that strict scrutiny “likely applies” because the Texas labeling law is a content-based regulation of speech.  The law requires the plaintiffs to speak a particular message that “alters the content of their” speech, here a government-scripted message on food labels and online that must be clear and conspicuous.   The plaintiffs pointed out that the required warning is not even true, since not one of the four jurisdictions referenced in the legislation (Australia, Canada, the European Union, or the United Kingdom – note that there isn’t a single SEC football team in any of those places, and they probably cannot barbecue decent brisket) actually states that any of the listed ingredients are “not recommended for human consumption.”  For the court, the key is that Texas showed neither the compelling state interest nor the narrow reach necessary to survive strict scrutiny.  Adios, silly, bossy statute.  

The court made the smart move of ruling on alternate grounds.  That makes the AG’s appeal more difficult. Even if the case was viewed through the lens of the Central Hudson commercial speech standard, the Texas labeling requirement would not “pass muster.” That is, it flunks intermediate scrutiny.  Yes, the state has a “substantial interest in supporting the health and well-being of its citizens by promoting better ingredients in foods sold in Texas.”  But compelling sellers to warn consumers of a potential risk never confirmed by any regulatory body or of a hazard not known to more than a small subset of the scientific community does not “directly and materially” advance the government’s interest.  Moreover, forced speech is not a “narrowly tailored” approach. The state could spend its own resources in its own advertising campaign rather than force the plaintiffs to speak.  Market based solutions, including the speech market, are usually better. 

Other arguments offered by the plaintiffs fared less well. But that’s okay — a win is a win. The court held that the vagueness and preemption arguments did not meet the preliminary injunction threshold.  The obstacle preemption argument faces the dreaded presumption against preemption, which would require adjudication of the falsity of the compelled statements. See you at summary judgment. For now, it is too early for that, and maybe the court will never get there, because, as the court held, the plaintiffs likely will prevail on the First Amendment ground.  

In any event, the deprivation of a First Amendment right constitutes irreparable harm, and an injunction protecting First Amendment rights is always in the public interest.  Accordingly, AG and senatorial candidate Paxton is enjoined from enforcing Section 9. 

The lesson here is for companies to take the First Amendment argument seriously, as we have advocated, particularly as to off-label use. That lesson is actionable.  Less actionable is another lesson: as has become the case all too often in this republic,  the executive and legislative branches do too much, or do not enough, or simply do dumb. More and more, the only adult in the room is the judiciary.  

If you are interested in this sort of thing – and why wouldn’t you be? – take a look at our post on American Beverage Ass’n v. SF.  It was another First Amendment challenge to a food warning law by the ABA.  Other recent First Amendment food posts are here and here.   

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The recent decision in Cousin-Sabra v. Smith & Nephew, Inc., 2026 U.S. Dist. LEXIS 25576 (E.D.N.C. Feb. 5, 2026) is short and straightforward. So too, therefore, will be this post. What we have is an ambitious plaintiff who filed a products liability/medical malpractice case against her doctors and the manufacturer of the device they used in her rotator cuff surgery– and, before the ink was even dry, asked for the keys to the warehouse.

Before the parties even held their Rule 26(f) conference—and while multiple Rule 12 motions to dismiss were pending—the plaintiff sought leave to serve sweeping, full-bore (aka expensive) discovery. Not targeted discovery. Not issue-specific discovery. We’re talking “categories” of all kinds of documents and records that the court struggled to even call proper “requests.” Id. at *4-5. 

Courts can authorize expedited discovery, of course. But only if the request is reasonable “in light of the totality of the circumstances.” And here, the totality was not the plaintiff’s friend.

First, procedural posture matters. A lot. Expedited discovery is particularly disfavored when Rule 12 motions are pending. There’s a reason for that. The whole point of Rule 12 is to test the legal sufficiency of the complaint before the parties incur the time and expense of merits discovery. If plaintiffs could demand costly discovery before a court rules on pleading-based motions, Rule 12 would become little more than an academic exercise—an expensive prelude to discovery instead of a gatekeeper. In this case, the broad discovery could not be said to be needed to assist in preparing a response to the motions to dismiss.  Id. at *3.

Second, the requests were anything but “narrowly tailored.” The court had no difficulty seeing that the proposed early discovery was “sweeping in scope” and indistinguishable from “full-blown merits discovery.” Id. at *7. This wasn’t a scalpel; it was a trawling net. When a party seeking expedited discovery can’t even pretend to aim narrowly at a discrete issue, that’s usually a tell.

Third, there was no irreparable harm lurking around the corner.  Plaintiff’s argument was that early discovery was needed because the documents are in the exclusive control of the defendants and she needs them to prepare the prosecution of her case.  That’s not irreparable harm.  That’s just discovery in a products liability case. Id. at *7-8. 

Finally, plaintiff could not show any risk that evidence would be lost absent immediate production. At best plaintiff speculated that “automated retention systems” could cause materials to become unavailable. But speculation about hypothetical loss of evidence won’t do. Particularly where defendants acknowledge, as they did here, their preservation obligations. Id. at *8-9.

In short, every relevant factor cut the same way—no expedited discovery. The most efficient ruling can also be the most obvious one. And the easiest way to discovery should be to survive a motion to dismiss first.

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Last month we were one of the first on the web with a review of the new Reference Manual on Scientific Evidence, Fourth Edition.  Since it was nearly 1700 pages long – literally longer than “War & Peace” – we did only the most cursory of analyses, describing differences in topics and authors and addressing some AI issues that we thought pertinent.

But then things started happening that were way over the heads of a few blogging defense hacks.  We had remarked that the last chapter (“Reference Guide on Climate Science”) seemed like an unusually narrow – we called it “niche” − topic compared to everything else the manual covered, all of which had trans-substantive application to litigation.  To us, it seemed a little like having a section on accident reconstruction, or fire causes and origins, or even pelvic mesh science.

But it turned out to be much worse than that.  The purported climate change chapter has been exposed as a pro-plaintiff hit job.  As the Wall Street Journal put it recently:  “The Federal Judicial Center tried to pass off one-sided propaganda as ‘settled science’” (behind paywall here).  Climate change is not really our area, so for all the gory details, we refer you to this letter that the Attorneys General of more than half the states recently sent to the director of the Federal Judicial Center (“FJC”) (which sponsored and published the Reference Manual).  Here’s a taste of what is in that heavily footnoted six-page letter:

The problems in the climate reference section seem to have started in selecting its authors.  Jessica Wentz and Radley Horton are both connected with climate studies programs at Columbia University.  And Columbia and its research partners have long viewed lawsuits against States, traditional energy producers, and others as “opportunities” to “resolve” what they see as “the pressing dangers created by climate change.”  Wentz and Horton themselves have applauded litigation as a tool to advance their preferred political objectives, complaining that the “political sphere in the United States continues to be clouded with false debates over the validity of climate change.”  As they see it, the courtroom provides a better venue.

Attorneys General letter at 2 (four footnotes omitted).

The Attorneys General’s letter requested that the FJC withdraw the “Climate Science” chapter.  Id. at 2, 5.  And that’s exactly what happened.  In early February – about a week after the AGs sent their letter − the FJC removed the Climate Science section from the free online copy of the Manual on Scientific Evidence we mentioned as being available in our initial post.  The table of contents (page xvi of the PDF) now says, and we quote:  “** The FJC omitted Reference Guide on Climate Science on 2/6/2026”  That statement is reiterated on p. 1561, where the section used to start.

Several of our readers had raised similar concerns to us, and we had started to research them, but events outran our own comparatively puny efforts.  We had planned to analyze both authors’ (Wentz & Horton) published works, and whether the citations in the 302 footnotes to the “Climate Science“ chapter were disproportionately to articles by authors who served as p-side experts in climate-related litigation.  Given that the chapter has already been withdrawn, there’s no need to complete that research – particularly since it’s tangential to the prescription medical product focus of the Blog.

But we did enough of our own research to determine that the criticisms of the Reference Manual’s “Climate Science“ chapter were 100% accurate.  First, and most obviously, the lead author has been affiliated for many years with the Sabin Center for Climate Change Law.  That entity is about as far from objective as it is possible to get, since, as the first page of their website states: “The Sabin Center develops legal techniques to combat the climate crisis and advance climate justice.”  They say it; not us.

What research we did into the authors’ published works led us pretty quickly to this article:  Jessica Wentz, Benjamin Franta, “Liability for Public Deception:  Linking Fossil Fuel Disinformation to Climate Damages,” 52 Envtl. L. Rep. (ELI) 10995 (2022).  The name says it all.  It’s a polemic in favor of increasing liability for precisely the topic that the Research Manual’s “Climate Science” chapter covers:

This Article examines how tort plaintiffs can establish a causal nexus between public deception and damages, drawing from past litigation, particularly claims filed against manufacturers for misleading the public about the risks of tobacco, lead paint, and opioids. . ..  The Article concludes with a discussion of the[] potential strategies and evidentiary sources.

Id. at 10995 (emphasis added).  We know exactly what the reference to “tobacco, lead paint, and opioids” means – pursuit of the same sort of broad, vague “public nuisance” litigation that we’ve been opposing ever since it first surfaced in firearms litigation more than twenty years ago.

Thus, it didn’t take us very long to confirm the worst of what our readers had indicated to us.  Ms. Wentz is an overt pro-plaintiff ideologue.  The Federal Judicial Center and the National Academy of Sciences had no business letting these p-side advocates anywhere near a project intended “to provide accurate, objective information and education” for judges.  Reference Manual, 4th ed. at iv.  We’re happy that the FJC pulled their blatantly biased chapter down so quickly, but we’re appalled that it happened in the first place.  That chapter had to be in the works for years.  Where was the FJC’s adult supervision?  Here, as well, we find ourselves in agreement with the concluding observations in the AGs’ letter:

Really, this issue transcends climate policy.  If the [FJC] can predetermine scientific questions in climate cases, what prevents it from doing the same for pharmaceutical liability. . .?  The precedent is dangerous regardless of one’s views on climate change. . . .  The Center should also establish procedures to prevent similar advocacy-based chapters in future editions.

AGs’ Letter at 4-5.  Something went badly awry in the Reference Manual’s internal editorial process – and stayed wrong for a long time.

We can’t say this breakdown in judicial neutrality is over and done with, however.  We direct our readers’ attention to chapter 2, entitled “How Science Works.”  While we agree with the chapter’s observation that “[s]cientific consensus is generally reached over the course of multiple studies conducted by different groups pursuing different lines of inquiry,” Reference Manual at 41, that chapter includes several citations to the works of a conspiracy theorist, Naomi Oreskes, who doesn’t believe that at all.  See Chapter 2 at nn. 2, 10, 85, 130 (three times).  One of her books is Merchants of Doubt:  How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Climate Change.  That book is cited four times in the “How Science Works Chapter – more than anything else referenced in that chapter, and no other author is cited anywhere near as often.  As is clear from its title, Merchants of Doubt is hardly the textbook-type publication we would expect to see prominently featured in a Reference Manual chapter.  Instead, it’s a screed against defendants in litigation, as is evidenced by its description on Amazon.com:

Merchants of Doubt has been praised-and attacked-around the world, for reasons easy to understand.  This book tells, with “brutal clarity” (Huffington Post), the disquieting story of how a loose-knit group of high-level scientists and scientific advisers, with deep connections in politics and industry, ran effective campaigns to mislead the public and deny well-established scientific knowledge over four decades.  The same individuals who claim the science of global warming is “not settled” have also denied the truth about studies linking smoking to lung cancer, coal smoke to acid rain, and CFCs to the ozone hole.  “Doubt is our product,” wrote one tobacco executive.  These “experts” supplied it.  Merchants of Doubt rolls back the rug on this dark corner of American science.

The “How Science Works” chapter cites Merchants of Doubt for the following propositions:

  • “Complicating matters, public relations campaigns have misled the public about the true state of scientific consensus regarding certain scientific issues.”  [fn.5]
  • “While the complex and iterative processes that went into establishing depletion of the ozone layer by CFCs are commonplace in science, the speed with which societal and political action followed scientific consensus in this case may be unusual.”  [fn.10]
  • “The problem of scientists with legitimate expertise in one field weighing in on a scientific question outside their area of expertise is a pernicious one that has affected public acceptance of science and policy on issues such as climate change and tobacco exposure.”  [fn.85]
  • “This [perception of scientific consensus] sometimes occurs as a result of strategic manipulation from stakeholders who stand to be harmed if the public were to understand the true state of scientific consensus surrounding the hypothesis, as has occurred with, for example, the health effects of tobacco, ozone depletion, and climate change.”  [fn.130 – also citing two other works by Oreskes]

Tobacco and climate change are matters that are still very much in litigation.  The “How Science Works” chapter of the Reference Manual thus suffers, to a lesser extent, from the same pro-plaintiff bias that permeated the now-withdrawn “Climate Science” chapter.  Why the new authors of “How Science Works” would choose to present a pro-plaintiff zealot’s work as reflecting “the true state of scientific consensus” in an FJC publication is beyond us.  We compared the chapter of the same name in the Third Edition of the Reference Manual (available here) to see if we had missed anything.  We did not.  The Third Edition contained none of the pro-plaintiff polemic or conspiracy theories that we have found in its Fourth Edition successor.

While we haven’t encountered plaintiffs in prescription medical product liability litigation using Ms. Oreskes’ work in attempts to bias judges and juries, we’re well aware of analogous efforts.  Plaintiffs have attempted to introduce a similarly scurrilous screed – with even a similar title – into evidence in cases of the sort we litigate, specifically D. Michaels, Doubt Is Their Product.  Again, the palpable pro-plaintiff bias of that book is evident from its Amazon description:

In this eye-opening expose, David Michaels reveals how the tobacco industry’s duplicitous tactics spawned a multimillion dollar industry that is dismantling public health safeguards.  Product defense consultants, he argues, have increasingly skewed the scientific literature, manufactured and magnified scientific uncertainty, and influenced policy decisions to the advantage of polluters and the manufacturers of dangerous products.  To keep the public confused about the hazards posed by global warming, second-hand smoke, asbestos, lead, plastics, and many other toxic materials, industry executives have hired unscrupulous scientists and lobbyists to dispute scientific evidence about health risks.  In doing so, they have not only delayed action on specific hazards, but they have constructed barriers to make it harder for lawmakers, government agencies, and courts to respond to future threats.  The Orwellian strategy of dismissing research conducted by the scientific community as “junk science” and elevating science conducted by product defense specialists to “sound science” status also creates confusion about the very nature of scientific inquiry and undermines the public’s confidence in science’s ability to address public health and environmental concerns.

Only once that we know of were plaintiffs in prescription medical product liability litigation successful in exposing a jury to this particular piece of pro-plaintiff propaganda.  The result was predictably horrific, and fortunately promptly reversed, albeit on other, even more serious, evidentiary grounds.  See In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753, 787 n.71 (5th Cir. 2018) (“We decline to address defendants’ remaining evidentiary challenges regarding . . . the Doubt is Their Product book. . . .  The district court should weigh carefully the applicability of Rules 403 and 404(b)”).  Other courts have recognized this disinformation for what it is and have excluded it when plaintiffs tried similar shenanigans.  First, it is inadmissible hearsay;

It seems that in addition to maybe offering this excerpt to impeach an expert on how they formulated their opinions, Plaintiffs are also attempting to offer the book to assert that [defendants’ experts] are corrupt, and anyone who relies on them is also corrupt.  Under this light, it does look like “classic” inadmissible hearsay.  Further, this likely does not fall into the learned treatise exception, as Doubt Is Their Product does not qualify as a reliable authority as required by the rule.  It appears through the briefing that the author of Doubt is Their Product has a clear goal throughout his book, which may speak to bias.  Accordingly, the Court finds that this book serves as inadmissible hearsay. . . .  

King v. DePuy Orthopaedics, Inc., 2024 WL 6953089, at *2 (D. Ariz. July 9, 2024) (citations omitted) (emphasis original).

Second, treating books like Doubt Is Their Product as evidence is grossly prejudicial to defendants:

Not only is this information irrelevant to [defendants’ products], and the facts underlying the case here, but it also has the goal of likening Defendants, and possibly their experts, to notable “corporate villains” that many of the jurors likely have heard of and formed negative opinions about.  Accordingly, because there is minimal probative value to this information [,] which is substantially outweighed by prejudice to the Defendant [it] will be precluded under Rule 403.

Id. (citing Pinnacle Hip).  Accord Sarjeant v. Foster Wheeler LLC, 2024 WL 4658407, at *1 (N.D. Cal. Oct. 24, 2024) (Doubt Is Their Product is “both hearsay that does not come within any exception, irrelevant, and highly prejudicial under Rule 403.  It is not the type of material that an expert in the field would rely upon to form their opinion under Rule 703”); see also Evans v. Biomet, Inc., 2022 WL 3648250, at *4 (D. Alaska Feb. 1, 2022) (quashing subpoena issued to defendant’s expert for material “related to Doubt Is Their Product”).

The way we look at it, Oreskes’ Merchants of Doubt is just as utterly plaintiff biased and unacceptable in a judicial proceeding as is Michaels’ Doubt Is Their Product.  We wish we could say that we were “shocked” at finding six citations to her work (more than to any other author) in the “How Science Works” chapter of the Reference Manual, but after the spectacular flame-out of the “Climate Science” chapter, we were actually not all that surprised.  The problems with the “How Science Works” chapter seem to be another manifestation of the same rottenness in the FJC’s version of the State of Denmark.  The FJC should pull these references from “How Science Works” and revise their internal editorial procedures to ensure that nothing like this happens again.

The role of the Federal Judicial Center, which created and published the Reference Manual, is “is to provide accurate, objective information and education” for judges.  “About the FJC.”  We don’t know how this mess came about, or who selected the authors and reviewed their work pre-publication.  To people like us – on the outside looking in − the entire process seems opaque and mysterious.  But as for “objectivity,” somebody or more likely several somebodies, badly dropped the ball.

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Since the beginning of the Blog, we have shilled for only one product:  Bexis’ “Drug and Medical Device Product Liability Deskbook” (published by Law.com and updated twice annually).  While Bexis is continuing the blog in 2026 (after he turned 70), he is not continuing to update this treatise.  Frankly, it’s a lot of work, and Bexis in his dotage no longer wants to write things with footnotes.

Over the last year, Bexis has informally attempted to find a successor willing to take over and continue his treatise, but without success.  It is a lot of effort, but it has its rewards, too.  It requires creating Lexis/Westlaw searches that will produce every prescription medical product liability litigation-related decision.  Then, an author must be read, and categorize by relevant chapter(s), all of these cases.  Then, when a chapter update is written, the author must read the cases (or the relevant parts) again, and add citations to each case in the footnote(s), and sometimes text, where it belongs.  Often, entirely new paragraphs suggest themselves.  ALM’s editors then run the changes and provide proofs for final, handwritten edits.  Repeat the process twice a year for different chapters.

The rewards are:  (1) suddenly knowing more than almost all other lawyers about what’s going on in prescription medical product liability litigation, and being able to pick up patterns and predict trends; (2) instant authority, as a name author of one of ALM’s most prominent publications; (3) helping your firm save clients lots of money by having pre-done research available; and (4) research synergies leading to numerous other publication opportunities.  It’s no accident that you can find Bexis’ name all over – the Blog, amicus briefs, DRI publications, 360, FDLI, ACI, PLAC – since he doesn’t have to reinvent the research wheel every time he writes about something.  Whoever took his place would have the same built-in advantages in the thought leadership arena.

Anyone taking over the project would also have some help.  Bexis is continuing with the Blog.  So he has to continue reading the cases that his own searches turn up.  It’s no big deal for him to continue adding new cases to the “chapter update” document that he’s been using for this treatise for the past 20+ years.  Bexis will happily work with any successor author.

So here is the pitch to our readers (and their firms):  If any of you would like to take over the editorial function for the Drug and Medical Device Product Liability Deskbook, feel free to contact Bexis directly.  Don’t kid yourselves, these semiannual chapter updates (at least the way Bexis did them) each take a month to prepare – it’s hard work.  But don’t sell yourself short, either.  All that work will increase your, and your firm’s, profile in the competitive and remunerative prescription medical product liability litigation defense field.

Bexis will put you in touch with his editors at Law.com, and you can take it from there.

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This post is not from the Reed Smith or Dechert sides of the blog.

We hope we’re not the only ones distracted by the Winter Olympics. We’re breathless from Breezy Johnson taking gold in the downhill, Jordan Stoltz emerging as the U.S. speed-skating phenom, Jessie Diggins battling bruised ribs to take bronze in the 10K cross country freestyle, and Ilia Malinin throwing in a back-flip in his skating routine just for kicks—despite it not earning him any points. Not to mention short-track skating, biathlon, luge, moguls, snowboard-cross, bobsledding, the Olympic debut of ski mountaineering, and all kinds of other ski and snowboarding events where the contestants either fly down mountains at cataclysm-embracing speeds or hurl themselves into the stratosphere while contorting themselves in twists and turns that make us dizzy. Combine that competition and athleticism with the Olympic themes of unity and sportsmanship, and you can see why we’ve got Olympic fever.

We were particularly enthralled with the U.S. mixed-double’s curling team. This is from humble bloggers who, other than every four years, have no idea what curling is. But when the Winter Olympics roll around, we’re watching to see who’s dominating the house and who has the hammer. The U.S. mixed doubles team had never taken home a curling medal. This year’s team, Cory Thiesse and Korey Dropkin, absolutely dominated the round robin and earned a spot in the medal round. After a magnificent shot in the last end (like a game winning home run in the bottom of the ninth), the U.S. defeated defending gold-medalist Italy for a chance to play for the gold medal. While “Corey and Korey” ending up taking home silver, it was the first ever medal for the U.S. in mixed curling and the first ever Olympic medal in curling for an American woman. What a run.    

One of the curling commentators noted that Korey Dropkin was one of the best sweepers in the game. While it may be a stretch to connect curling to the legal side of these posts, we think it is fair to note that mass torts defendants often engage in years of clean up after securing victories in mass torts. Call it sweeping the house if you will. Case in point is the Zantac litigation. The defendants secured litigation-ending rulings excluding plaintiffs’ general causation experts in the federal MDL (which we posted about here and here).  Plaintiffs then fled to Delaware (of all places to see mass torts plaintiffs flocking, we continue to be surprised and disappointed at this trend).  The Delaware trial court refused to follow the well-reasoned decisions from the MDL and appeared to give new life to the Zantac litigation (see this post), but the Delaware Supreme Court reversed and remanded with instructions for the trial court to apply Delaware’s Rule 702 consistently with the federal rule (see here).  

Continue Reading The Zantac Defense Has the Hammer in Delaware
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Here in the United States, Lawyers for Civil Justice (LCJ) encourages lawyers to Ask About TPLF, also known as third party litigation funding.   

LCJ and others are advocating for an addition to the Federal Rules of Civil Procedure that would require litigants to disclose the involvement of litigation funders in cases, just like the Rule 26(a)(1)(A)(iv) currently requires defendants to disclose insurance coverage.

The rationale for litigation funding disclosures and insurance coverage disclosures are the same:  Unless these non-parties and their otherwise hidden vested financial interests are disclosed, courts and other litigants are blind to who is controlling litigation decisions, whether there are lurking conflicts of interest, and whether non-litigation interests (the demands of the funder or the terms of the funding agreement) are driving litigation and settlement strategies. 

Another concern:  Without disclosure, do those undisclosed entities have access to your confidential discovery information in violation of court protective orders?

The impending implementation of the European Union’s Product Liability Directive (PLD) had us wondering about the state of TPLF in Europe.  If torts in Europe are going to turn mass, litigation funders will not be far behind. 

In fact, they already are there.  Some U.S.-based litigation funders expanded operations into Europe in recent years, in recognition that the Representative Actions Directive (RAD), with a June 25, 2023 implementation deadline, already was making the continent a more litigation-rich target.  (The RAD also has a feature that we don’t have here in the U.S.: “Qualified Entities” instead of class representatives.  But that is for another post.)

Fortunately, it seems Europe loves a good report, and the European Commission published one last year:  Mapping Third Party Litigation Funding in the European Union, which we will call the “EU TPLF Report” to get in our minimum daily allowance of acronyms. 

The report maps TPLF-related legal frameworks across all 27 EU Member States and certain non‑EU jurisdictions (Canada, Switzerland, the United Kingdom, the United States) in response to the European Parliament’s Resolution of September 13, 2022, Responsible Private Funding of Litigation. 

The ultimate goal was to help the European Union decide if TPLF regulation is needed EU-wide, and on a consistent basis, beyond Article 10 of the EU RAD.  That part of the RAD provides only vague guidance and no hard rules: (“Member States shall ensure that” in representative actions funded by TPLF, “conflicts are prevented” and the litigation funder’s economic interest “does not divert the representative action away from the protection of the collective interests of consumers.”). 

Not surprisingly, the EU TPLF Report found that few EU countries have specific TPLF laws beyond those tied to the gentle suggestions of Article 10 of the RAD, and what limits do exist come from more general contract law, civil procedure, consumer protection rules, and legal ethics, with a smattering of banking and financial regulation thrown in.

Claimants generally can assign their litigation interests, and freedom to contract generally reigns.  Sometimes, in representative actions, disclosure to the court is required, but outside that context disclosure hardly ever is required.   

In loser-pays jurisdictions, litigation funders usually are not automatically or directly liable to the successful defendant who wins an adverse cost award when the funded case fails.   The losing party (the funded claimant) still remains primarily responsible for paying the successful defendant’s costs, although the funding agreement often will require the funder to pay or reimburse those costs, but often only up to a specified maximum. 

The report also concludes that TPLF is widely in use across the EU, including in consumer protection actions.  In terms of the terms:

  • Common structures provide the funder with a percentage of recovery (often in the 20-30% range) and/or multiples of committed costs;
  • “Waterfall” provisions require return of the funder’s investment before remaining proceeds are distributed; and
  • Funders usually control the choice of lawyer and whether settlement occurs, and have a say on strategy.  Sometimes, the funder can terminate the funding agreement mid‑litigation.

As in the U.S., there are TPLF advocates and detractors.  The EU TPLF Report states that proponents perceive TPLF as providing better access to the courts, a higher level of advocacy in complex matters, and a filtering-out effect where weaker claims go unfunded and thus unfiled.   

The perceived problems will sound familiar:  Hidden conflicts of interest, undue funder influence on the course of litigation and settlement, and the promotion of less-worthy litigation aimed at extracting settlements.  One fear: Litigation funders could use a shotgun approach to fund duplicative litigation across jurisdictions against the same defendant, leveraging more claimant-friendly countries and volume pressure to extract settlements.  These concerns were particularly noted (no surprise) for product liability lawsuits, as well as patent litigation. 

Will this result in new TPLF regulation in the EU?  Maybe, we will see.  The Commission will use the study to support policy development in response to the European Parliament’s Resolution.

The EU TPLF Report did conclude that rules requiring disclosure would be the most effective type of regulation.  Just like the proposed Federal Rule of Civil Procedure.   

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Our law school days were long ago.  Reagan was the president. Footloose and Beverly Hills Cop topped the movie box office. Prince made great music, Lionel Ritchie made good music, and Macca and Jacko teamed up to make awful music.  The Soviet Union boycotted the 1984 Olympics, which made the games … really excellent.  

Even way back then, it seemed that asbestos litigation was on its last legs.  The main asbestos manufacturer had plunged into bankruptcy.  When we graduated, we had no expectation or ambition that one day we would work on asbestos cases. It was hamburger law, a machine to grind up defendants and extrude settlements.  There seemed to be an entirely different rule book for asbestos law.  Many courts wouldn’t entertain dispositive motions until the week before trial.  Everything seemed design to churn out a “resolution.”  Most top AmLaw firms looked down on asbestos law, and so did we. 

Cue the flipping calendar pages.  Inventive (euphemism alert) plaintiff lawyers were not quite ready to get off the asbestos gravy train. They found wave upon wave of other defendants. It is as if Nietzsche’s eternal recurrence thought experiment foresaw asbestos law:  “This life as you now live it you will have to live once again and innumerable times again; and there will be nothing new in it, but every pain and every joy and every thought and sigh must return to you, all in the same succession and sequence.”

Good old Nietzsche got asbestos litigation right, except for the “joy” part. Decades later, against all expectation, we found ourselves representing a brake manufacturer in asbestos lawsuits. We huddled in crowded deposition conference rooms, waiting to hear how many of the 80+ defendants named in the complaint would actually be mentioned by the plaintiff. Usually, fewer than a third of the named defendants had anything to do with the plaintiff.  Did the courts care that the complaints were drafted with no concern for reality?  Nope. Just keep the machine humming. The overbroad complaints were the work of slobs – slobs with Porsches and private jets. It was a dispiriting practice. And it appears to be never-ending.  

The asbestos litigation du jour involves talcum powder. We’re talking about cosmetic talc. There isn’t a decent speck of epidemiological evidence showing that cosmetic talc causes any disease whatsoever.  Nevertheless, plaintiff attorney persistence, junk science, and judicial torpor have added up to several eye-watering verdicts.  (Judicial torpor is about as good as it gets when it comes to asbestos litigation.  There are some courts that actively favor the asbestos plaintiff bar. Read the latest ATRA list for horror stories.) 

Cosmetic talc litigation is hardly the crowning glory of the American judicial system.  Rules and science are banished from the courtrooms. It is an uphill run for any defendant.  But we will charge up that hill for our clients, trying to extract at least an ounce of justice and fairness from a flawed system. Again, one thinks of Nietzsche, or maybe the Camus retelling of the myth of Sisyphus. We’ll keep trudging uphill, sweating under the vast indifference of the skies and rank hostility of pro-plaintiff judges. 

We had no involvement in today’s case, In re Talc Based Powder Products Litigation, 2026 WL 318130 (N.J. App. Feb. 6, 2026), and we have not represented its defendant in any talc case. We read the case with interest because it confirms our suspicion that more than a few of the plaintiff asbestos firms take their, ahem, inventiveness to the point where ethical lines get blurred, smudged, or flat-out erased.  We have grown used to plaintiff talc experts who would find asbestos in panda tears.  Sometimes those experts even say that asbestos does not matter at all – that talc qua talc is the villain. Those experts  will also always always always find enough exposure to increase the risk of whatever injury is alleged.  Further, thanks to a recent RICO case filed against a plaintiff asbestos law firm in Illinois, we find our cynicism confirmed when it comes to plaintiffs whose deposition testimony is perfectly scripted to steer between implicating defendants and preserving later claims against various asbestos trusts. Those plaintiffs weave tales of dwelling in clouds of talc, applying talc after each one of their three showers per day.  

But we had never dreamt that plaintiff law firms would hire lawyers who had worked for talc companies as a way to gain advantages in settlement negotiations.  Well, whether we dreamt it or not, today’s case rouses us from our slumber. 

A major plaintiffs’ firm hired a lawyer who had worked for the talc defendant to do the same kind of work (claim evaluation) for it.  That lawyer had “participated for nearly two years in confidential strategy and settlement analysis of the talc litigation.”  He was one of the lawyers who had “led the overall strategy to secure a global resolution of the talc cases.”  Good grief. 

A sentient being might conclude that hiring away the other side’s lawyer would likely run afoul of a raft of ethical rules.  Shouldn’t the plaintiff firm be disqualified after getting access to an opponent’s most sensitive litigation information? What is more sensitive than settlement strategy? But the plaintiff counsel claimed that, because the turncoat was hired in a “non-legal” capacity, none of those ethical rules applied.  The plaintiff counsel also argued that the talc company had not proved that the turncoat lawyer had actually disclosed any client confidences.  Those excuses had been enough for the trial judge, but the New Jersey appellate division unanimously reversed and ordered disqualification.   

Rule of Professional Conduct (RPC) 5.3 lays out the circumstances in which a lawyer is responsible for the conduct of nonlawyers within or outside the firm that would be a violation of the RPC if engaged in by the lawyer.  It did not matter if the turncoat lawyer was technically acting as a restructuring consultant rather than a lawyer.  It does not matter if the turncoat lawyer was technically not employed by the plaintiff firm.  He was clearly “associated” with the plaintiff firm. 

Once RPC 5.3 was triggered, as it was here, the issue is the applicability of RPC 1.9, which provides that “a lawyer who has represented a client in a matter shall not thereafter represent another client in the same or a substantially related matter in which that client’s interests are materially adverse to the interests of the former client unless the former client gives informed consent confirmed in writing.”  

The plaintiffs’ firm “knowingly collaborated” with the turncoat lawyer on the same issue and in the same litigation on which the turncoat had formerly been on the other side.  The plaintiff firm admitted that it could not have employed the turncoat lawyer as a lawyer without offending RPC 1.9. But whether or not you call what the turncoat did legal work, it involved strategy for settling litigation.  

And now we get to high (or low) comedy.  The turncoat argued that his work on behalf of the plaintiff firm was aligned with the interests of his former client, because both the former client and the plaintiff firm wanted resolution of the talc claims.  We have said before that the word “disingenuous” is overused in our business, but the appellate court rightly used that word here. Indeed, “chutzpah” would also have worked.  Sure, both the plaintiff firm and talc company were looking to settle the litigation, but does anyone doubt that the plaintiff firm wants to receive as much money as possible, and the defendant would prefer to pay as little as possible? The turncoat lawyer had played an important role for the talc company in devising its settlement strategy.  How could the plaintiff firm’s access to such settlement strategy not adversely affect the talc company’s interest? The plaintiff firm and the turncoat admittedly “collaborated” on a settlement proposal to the talc company. That collaboration occurred with the plaintiff firm’s knowledge that the turncoat had “previously negotiated on a settlement of these same talc claims.”  The appellate court concluded that disqualification of the plaintiff firm was necessary: “The rules of professional behavior are not branches which bend and sway in the winds of the job market but are instead the bedrock of professional conduct.” 

The plaintiff firm says it will appeal this disqualification.  It is a big deal.  Of course, having been around the block a few times with asbestos litigation, we suspect that this sort of ethical line-stepping is merely the tip of a very rotten iceberg. 

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As our slew of recent posts on standing demonstrate, plaintiffs’ lawyers continue their search for a version of federal jurisdiction that does not require anyone to have been hurt. This time, the vehicle was a box of band-aids—and the court declined to take the ride, dismissing the case in its entirety.

In Aronstein v. Kenvue, Inc., 2026 WL 266713 (D.N.J. Feb. 2, 2026), plaintiffs brought a putative class action alleging that certain adhesive bandages contained PFAS at “harmful” levels. What they did not allege is that anyone was actually harmed. No rashes. No illness. No adverse health effects. No malfunction. Just the existential disappointment of learning—after the fact—that the band-aids they purchased allegedly contained something plaintiffs would have preferred they did not.

The court’s standing analysis was straightforward. Article III requires an injury in fact, and plaintiffs failed to allege one. Undeterred by the lack of actual injury, plaintiffs relied on a “benefit of the bargain” theory. According to the complaint, plaintiffs claimed that because the bandages contained PFAS they were worth less than what plaintiffs paid for them.  The complaint never claimed that plaintiffs suffered any adverse health consequences from using the bandages. Nor did it allege that the bandages failed to work as intended. To the contrary, plaintiffs got exactly what they paid for—a bandage that stuck. It covered their scrapes, cuts, and wounds. Id. at *5. That, it turns out, still counts as performance.

Plaintiffs also alleged they were misled by statements such as “we use better ingredients” and “safety is our top concern.” The court rejected that argument as well, holding that these generalized marketing statements are classic product puffery. Crucially, none of the statements referenced PFAS or made specific representations about chemical composition. Id. at *5-6. Aspirational claims about quality and safety do not become actionable simply because plaintiffs wish they meant something more precise. And the statements could all be true even if PFAS were present. Beyond alleging that testing detected some PFAS, plaintiffs cited no studies showing that the presence of PFAS in adhesive bandages causes harm or adverse health consequences to users. Id. at *6 & n.8. There were no allegations regarding dose, exposure, or any plausible mechanism of injury. Temporary contact with a bandage on intact skin, standing alone, was not enough.

Nor did Plaintiffs allege any facts to support a price premium theory. They did not allege what they paid, what they should have paid, or what other presumably PFAS-free products cost. While the complaint contained “passing reference” to two other brands, plaintiffs did not allege they would have purchased those brands or what those brands cost.  Id. at *7. Instead, the complaint relied on the now-familiar formulaic assertion that plaintiffs paid more than they otherwise would have, untethered to any factual support. The court had little trouble concluding that this was insufficient.

Plaintiffs’ request for injunctive relief fared no better. Injunctive relief is about the possibility of future harm. But speculative risk, without facts making it plausible, does not satisfy Article III. “[T]o pursue injunctive relief, the risk of harm must be sufficiently imminent and substantial such that exposure to the risk of harm itself generates an independent injury.” Id.

First, plaintiffs alleged that they had stopped using the bandages altogether. The court noted that once a consumer claims to know about a potential health risk, the law assumes they act rationally—by discontinuing use. Having made that allegation, plaintiffs effectively pled themselves out of any plausible risk of future economic injury. An injunction, after all, cannot protect someone from a product they already say they will not buy or use again.

Second, and more fundamentally, because plaintiffs failed to allege any actual harm that would be caused from using the bandages in the first place, they necessarily failed to allege any credible risk of future harm. Speculation about what might happen someday is not enough to establish standing for injunctive relief—especially where the complaint offers no facts suggesting the product ever posed a real risk to begin with. An injunction is not a fallback remedy when standing is missing.

This case is a clean reaffirmation of several principles that continue to matter, even in creative consumer class actions. Standing requires an injury in fact. Benefit-of-the-bargain theories require facts, not labels. Puffery remains non-actionable. And alleged future harm must be plausible, not hypothetical.

Strip away everything else and this case is simple. Plaintiffs bought band-aids. They were supposed to stick. They did stuck. That’s not a legal injury. It is product performance.

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Not too long ago one of our bloggers (McConnell) critiqued a p-side law review article he had received from a lawyer on the other side with whom he was friendly.  Bexis isn’t as friendly with opposing counsel – Paul Rheingold being a rare exception.  But probably due to his activity in the American Law Institute, law professors on occasion have asked Bexis to review a law review article or two.  The articles are usually pro-plaintiff, as are most law professors.

Bexis can be a glutton for punishment – but knowing and being prepared to respond to what the other side might throw at us has some value.

Anyway, the article is by Luke Meier, a professor at Baylor Law School, who admittedly is at the plaintiffs’ end of the legal spectrum when it comes to prescription medical product liability litigation:

On one end of the spectrum is the notion that pharmaceutical defendants should be strictly liable (that is, liable even though the product was not defective) for injuries caused by their products.  I happen to fall into this camp. . . .

L. Meier, “Failure-to-Warn Suits Against Pharmaceutical Companies:  Physician Testimony, Causation, & Summary Judgment,” at p.46 (emphasis added).  It’s available here, although we caution that it doesn’t at all look like a finished product.  There are loads of citation-related typos and inconsistencies, a totally unattributed block quote (p.37), and a humorous “disinterred witness” typo that just happens to be in a hypothetical about shoveling (p. 42).  The article’s treatment of the law, however, is in no sense humorous.

Before it gets to its main thesis, however, the article makes some “background” points we can agree with.  Concerning manufacturing defects, “it is extremely rare for a pharmaceutical company to allow a product that has not been manufactured correctly to enter the market” (p.6 (footnote omitted)).  Concerning design defect claims, the article recognizes that “[p]ractically speaking, a plaintiff has very little chance of winning a design defect suit against a pharmaceutical manufacturer” (p.10 (footnote omitted)).  We agree, although with respect to design defect claims, our primary reason is not the common-law quirks that the article addresses, but rather preemption.  As the Supreme Court has recognized, “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (citation omitted).  The FDCA’s “major change” category extends to anything that could cause the type of injuries involved in product liability litigation – as we’ve discussed many times, such as here.

Thus the article pushes informationally based “warning” liability as a plaintiff’s last, best hope.  The learned intermediary rule (in addition to preemption in many cases) stands in the way of the author’s pro-liability point of view, so it must somehow be neutered.  How does the article propose to do that?  By ignoring the time-honored requirement that a tort plaintiff has the burden of proving causation, to start.  “Burden of proof” appears exactly once in this 47-page article, in a footnote quotation from one of Bexis’ favorite cases.  Meier Article p. 20 n.147.

The traditional tort burden of proof in a warning case requires the plaintiff to establish, with affirmative facts, that a different warning would have prevented his or her claimed injury.  In non-learned-intermediary situations, the person being warned is the plaintiff, so the plaintiff is his or her own primary witness to establish what we call “warning causation.”  Thus, extremely self-interested plaintiffs can be expected to testify to whatever is necessary to establish a prima facie warning causation case.  The article acknowledges that, in some jurisdictions, plaintiffs receive the benefit of a “heeding presumption” (something we have long detested) in warning cases, but dismisses the presumption as “weak” in learned intermediary rule cases because the same affirmative evidence that defeats causation under the learned intermediary rule also rebuts this presumption (p. 8).  See also Beck & Vale, Drug & Medical Liability Deskbook §2.05[4], at 2.05-92-97 (updated 2024) (discussing ways to rebut a heeding presumption).  That is also true.

What’s critically different in a learned intermediary situation is essentially the reason for this article.  Causation testimony does not come from an interested plaintiff. Ironically, the article spends significant ink attacking the “credibility” of medical professionals, Meier Article pp. 3-4, 38-39, whereas the plaintiffs themselves – who would have to testify to causation if the learned intermediary rule were somehow disabled – get a free pass despite their far worse credibility problems.

Under the learned intermediary rule, to prove causation, evidence must exist that, if believed by the finder of fact, an additional warning would have made some change (often defined as not prescribing the product) in the prescribing physician’s treatment of the patient that would have prevented the injury.  The plaintiff bears the burden of coming forward with such evidence.  But the physician is ordinarily independent and thus not beholden to the plaintiff.  So the plaintiff must obtain warning causation evidence to meet the burden of proof from a witness whose testimony may well be adverse.  If the plaintiff does not, then s/he fails to meet the applicable burden of proof.  If the plaintiff does, then usually disputed issues of fact exist, and the case goes to trial.  The article criticizes that as “asymmetrical risk” (pp.26-27) and “presum[ing] causation is lacking” (p. 30), but that is simply how summary judgment works in the adversary system – requiring the party bearing the burden of proof to meet that burden before a trial is warranted.  The party with the burden of proof must come forward with evidence, not allegations and not speculation.  It’s that simple.

Several types of physician testimony will leave the plaintiff without facts sufficient to meet the usual burden of establishing the possibility of materially different treatment, thus entitling the defendant to summary judgment.  These are compiled in Bexis’ book (and often on the blog as well).  Here are the most common warning causation roadblocks in learned intermediary rule causation cases:

  • The prescribing physician never read the allegedly inadequate warning.  Bexis’ book §2.05[2], at pp. 2.05-35 to -40; blogpost.
  • The prescribing physician testified that s/he already knew the information omitted from the allegedly inadequate warning.  Id. §2.05[2], at pp. 2.05-18 to -29; blogpost.
  • The prescribing physician testified that, even had s/he received the warning the plaintiff demands, s/he would have done nothing differently.  Id. §2.05[2], at pp. 2.05-43 to -48; blogpost.
  • The prescribing physician did not consider the risk severe enough to affect the prescription decision.  Id. §2.05[2], at pp. 2.05-41 to -42; blogpost.
  • The prescribing physician testified that, after the plaintiff was injured s/he did not change any relevant treatment protocols.  Id. §2.05[2], at pp. 2.05-1 to -3.
  • There is no evidence at all concerning the prescriber, either because s/he was never deposed or s/he had died, and there is no heeding presumption to flip the burden of proof.  Id. §2.05[2], at pp. 2.05-53 to -57; blogpost.
  • Further, it is hardly impossible for plaintiffs to establish warning causation under the learned intermediary rule, as the numerous citations to summary judgment denials in Bexis’ book demonstrate.  Id. §2.05[3], at pp. 2.05-69 to -78.

Thus, the law on learned intermediary causation is exactly as stated in Bexis’ book:

In a learned intermediary case, it is “well settled” that a manufacturer’s inadequate warning is causal only if a different warning would have changed the physician’s (or use) decision, or would have altered the physician’s conduct in some other that would have prevented the plaintiff’s injury.

Id. at 2.05-6.  The accompanying footnote extends for nearly six pages of small (10 point) type and cites literally scores of cases.  That is the magnitude of what the Meier article proposes to do away with.

To replace all this law – hundreds, if not thousands, of decisions throughout the country – the Meier article offers the concept of “counterfacts” (pp. 41-45).  We’d never heard of that before, and this section of the article is notably lacking in supporting precedent, so we did what we usually do.  We researched it.  On Westlaw, allcases, the term appears exactly eleven times, and none of those cases use it the way the Meier article does, which is:

For purposes of failure-to-warn claims against pharmaceutical defendants, the “material” inquiry is whether the plaintiff would have avoided injury if the defendant had given the warning proposed by the plaintiff.  But this “material” point is not a “fact” − it is a “counterfact.”  As discussed above, the causation inquiry necessarily requires speculation about a world that never existed:  “Hypothesis and speculation are essential for determining causal connection, since every statement of causal connection asserts what would have happened if the facts had been different.

*          *          *          *

The pertinent question . . . is whether this testimony justifies summary judgment for the defendant.  On this point, the difference between “facts” and “counterfacts” matters. The complicated body of law regarding when the evidentiary record justifies summary judgment on a material fact simply cannot be applied the same with regard to counterfacts.  It is one thing to require a certain amount of evidence regarding a disputed event that actually happened, but it is nonsensical to apply this same standard to a hypothetical event that must be imagined.

Id. at 43-44 (footnote omitted).  For these propositions – including calling the opposite proposition “nonsense” – the Meier article cites no precedent and only the most general sort of tort treatises.

Thus, the Meier article would replace the plaintiff’s burden of proof with respect to “counterfacts” – defined as facts bearing on the likelihood of a possible alternative result – with nothing, that is to say “hypothesis and speculation.”  It proposes to overturn precedent nationwide (see Bexis’ book if you doubt us), and not just decisions having to do with the learned intermediary rule.  Most tort cases involve proof of what would qualify as “counterfacts” as the Meier article defines them.  All warning cases involve “what if” questions predicated on different warnings; only the recipients differ.  Crashworthiness, for another example, involves determining what a plaintiff’s injuries in a vehicular accident would have been with a differently designed vehicle.  Plaintiffs in other product liability litigation often claim that, had an additional safety feature been available, they would have used it.  Damages, particularly in commercial torts, are generally intended to place the plaintiff in the position s/he would have been in had the tortious conduct not occurred.

The article’s “counterfact” concept, in short, is not only unprecedented, but proves far too much.  That rationale – allowing “hypothesis and speculation” to substitute for facts in any case where an element of a claim involves an alternative set of facts – would push the law firmly towards the sort of absolute liability regime that Prof. Meier states that he favors.  Needless to say, we do not agree.

The article also advocates (pp. 32-33) relaxing the causation burden by inserting the plaintiff into the causation matrix with allegations that, while the recommended treatment might stay the same, the accompanying informed consent discussion might have mentioned the alleged risk.  We’ve addressed both of the two cases the article cites (as does Bexis’ book (pp 2.05-14 to -15).  We continue to think that they are directly contrary to one of the primary policy bases for the learned intermediary rule:  to prevent the law from interfering with or disrupting existing physician-patient relationships (Bexis’ book pp 2.03-6 to -9).  The only way that a plaintiff establishes causation in this informed consent variant is to claim that, had s/he received the additional informed consent information, s/he would have disregarded the prescriber’s medical advice and refused the recommended drug.  The article does not even address that inherent feature of letting plaintiffs testify (as they invariably will) that they would have rejected the medical treatment that their prescribers recommended.

Finally, we feel obliged to point out another way in which the Meier article diverges from the great weight of precedent, without acknowledging that it does so.  On several occasions, it suggests that FDA-approved drug warnings are somehow superior to, or more impactful than, other sources of medical information that doctors and other health professionals rely on.  Meier article at 3 (“a physician who is aware of academic literature discussing a particular risk might view that risk differently − and act differently − if a manufacturer deems the risk important enough to provide a warning”); 34 (“It is one thing for a doctor to be aware of information or risks because of the doctor’s own professional reading or conversations.  It is quite another thing, however, for a doctor to receive an explicit warning accompanying the drug”); p. 35 (“a doctor who was already aware of the risk might nevertheless refrain from prescribing the drug if explicit warnings are given by the manufacturer”); p. 35 n.2 (“manufacturer warnings . . . facilitate a potential medical malpractice claim”).  None of these statements is supported by any authority at all.

In this aspect, as well, the article (perhaps unintentionally) is contrary to established law.  Most medical malpractice cases hold that manufacturer warnings do not establish the medical standard of care, and in many jurisdictions FDA-approved drug warnings are not even admissible.

[D]rug manufacturers do not design package inserts and PDR entries to establish a standard of medical care.  Manufacturers write drug package inserts and PDR warnings for many reasons including compliance with FDA requirements, advertisement, the provision of useful information to physicians, and an attempt to limit the manufacturer’s liability. . . . Those considerations highlight the reasons expert testimony must accompany the introduction of PDR warnings to establish the applicable standard of care in prescribing a drug.

Morlino v. Medical Center, 706 A.2d 721, 729 (N.J. 1998).  For a complete discussion of the law on this subject, see our post here.  Far from being somehow superior to other sources of medical knowledge, a prescription medical product’s FDA-approved warnings are at best only a piece of the informational mix in medical malpractice/informed consent litigation, and they are in no way controlling or entitled to greater weight as the Meier article seems to suggest.

The author sought our views on his proposal.  You asked for it; you got it.

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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